Naproxen Sodium

Product NDC
50090-3352
11-digit product format
500903352
Labeler code
50090
Product ID
50090-3352_42ac836a-d093-438d-a363-de73f0bc0240
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA200629
Marketing category
ANDA
Marketing start
2011-10-31
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
550 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3352-3EA - Each50090-3352978242a9-6523-41ae-a343-d5adbfa6772412019-05-02
50090-3352-5EA - Each50090-33520a71c344-6e2a-45b4-9056-bf8f909f1d7112020-02-13
50090-3352-6EA - Each50090-3352d6ae9d3c-9a58-44e1-9d88-5c5db360fb0712021-09-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3352-35009033520320 TABLET, FILM COATED in 1 BOTTLE (50090-3352-3) 2018-01-290000-00-00NoNoCurrent
50090-3352-55009033520530 TABLET, FILM COATED in 1 BOTTLE (50090-3352-5) 2018-03-120000-00-00NoNoCurrent
50090-3352-65009033520660 TABLET, FILM COATED in 1 BOTTLE (50090-3352-6) 2018-07-120000-00-00NoNoCurrent